A Study to Assess Adverse Events and Change in Disease Activity in Adult Participants Receiving Intravenously Infused Telisotuzumab Adizutecan Alone or With Standard of Care in Participants With Post Adjuvant Circulating Tumor DNA Positive Colorectal Cancer and No Radiographic Evidence of Disease

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
AbbVie
Study ID
NCT07023289
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Telisotuzumab Adizutecan — DRUG
    Intravenous (IV) Infusion
  • Standard of Care — DRUG
    Standard of care treatment based on investigator's judgement to the active surveillance.

Study Details

Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide. The purpose of this study is to assess change in disease activity when telisotuzumab adizutecan is given alone compared to standard of care (SOC) given alone. Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. This study will be divided into two groups called treatment arms. In arm 1 participants will receive telisotuzumab adizutecan alone. In arm 2 participants will receive SOC alone. Approximately 140 adult participants with CRC will be enrolled in the study in 45 sites worldwide. In arm 1, participants will receive intravenous (IV) doses of telisotuzumab adizutecan alone. In arm 2 Participants will receive SOC alone. The study will run for a duration of approximately 51 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Key Dates

Start date
Sep 2, 2025
Status verified
Jun 2026
Primary completion
Nov 30, 2029
Completion
Nov 30, 2029

Study Design

Enrollment
140 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Telisotuzumab Adizutecan Monotherapy
    Participants will receive telisotuzumab adizutecan dose A as a monotherapy, during the approximately 51 month study duration.
  • Active Comparator: Standard of Care (SOC)
    Participants will receive SOC, during the approximately 51 month study duration.

Primary Outcome Measure

Percentage of Participants with disease free survival (DFS) Event [ Time Frame: Up to Approximately 51 Months ]

Central Contacts

Locations (22)

FacilityCityStateZIPSite coordinators
Clearview Cancer Institute - Huntsville - Cci Drive /ID# 278621HuntsvilleAlabama35805-
Providence Medical Foundation - Fullerton /ID# 274207FullertonCalifornia92835-3826-
USC Norris Comprehensive Cancer Center /ID# 274550Los AngelesCalifornia90033-
Mayo Clinic Hospital Jacksonville /ID# 274472JacksonvilleFlorida32224-
Moffitt Cancer Center /ID# 274372TampaFlorida33612-
University of Chicago Medical Center /ID# 274742ChicagoIllinois60637-
Johns Hopkins Hospital /ID# 275645BaltimoreMaryland21287-
Massachusetts General Hospital /ID# 273608BostonMassachusetts02114-
University of Michigan Health System - Ann Arbor /ID# 273511Ann ArborMichigan48109-
Scri Minnesota Oncology Hematology, P.A. /ID# 275149MinneapolisMinnesota55404-
Mayo Clinic-Rochester /ID# 273508RochesterMinnesota55905-
Northwell Health Center for Advanced Medicine. /ID# 275331Lake SuccessNew York11042-
Duke University Medical Center /ID# 279457DurhamNorth Carolina27710-
Northwest Cancer Specialists /ID# 275151PortlandOregon97227-1800-
Abramson Cancer Center at the University of Pennsylvania /ID# 275407PhiladelphiaPennsylvania19104-
SCRI Oncology Partners /ID# 274522NashvilleTennessee37203-
Texas Oncology - Central/South Texas /ID# 275154AustinTexas78705-
The Center For Cancer And Blood Disorders /ID# 278512Fort WorthTexas76104-
Texas Oncology-Grapevine /ID# 275155GrapevineTexas76051-
The University of Texas MD Anderson Cancer Center /ID# 273539HoustonTexas77030-
Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 274586FairfaxVirginia22031-
Virginia Cancer Specialists - Fairfax /ID# 274339FairfaxVirginia22031-

Find similar trials in Huntsville, AL

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Clearview Cancer Institute - Huntsville - Cci Drive· Huntsville, ALProvidence Medical Foundation - Fullerton· Fullerton, CAUSC Norris Comprehensive Cancer Center· Los Angeles, CAMayo Clinic Hospital Jacksonville· Jacksonville, FLMoffitt Cancer Center· Tampa, FLUniversity of Chicago Medical Center· Chicago, IL

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